Sr. Manager/Associate Director, Regulatory Program Management

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

QED Therapeutics, an affiliate within BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.

What You'll Do

We are seeking a Sr. Manager/Associate Director, Regulatory Program Management to support the Achondroplasia and related skeletal dysplasia regulatory team. This individual will partner closely with the Sr. Director, Program Management, SVP, Regulatory Affairs, and cross-functional team members to enable delivering on key regulatory and filing goals for the program. This position requires understanding of and experience in biotech/drug development, regulatory filings and project management for late-stage clinical programs. The ideal candidate will be developing leadership skills and will have exceptional attention to detail and organizational skills. The role requires someone who can organize projects effectively in a rapidly changing, fast-paced setting. We are looking for a self-starter that will help drive our achondroplasia program through to MAA and NDA filings and drive successful execution of our regulatory plans. Previous experience in a regulatory project management role within the pharmaceutical or biotech industry & experience with filings are a must.  

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate infigratinib, we seek to provide a treatment option to children living with Achondroplasia and their families. 

Responsibilities

• Work with the regulatory team to develop and maintain overall integrated project timelines across all regulatory deliverables, including NDA/MAA marketing application timelines
• Develop and maintain dashboards to identify and monitor critical items in preparation of global filings
• Develop and maintain timelines for pressure testing submission scenarios (i.e., base case, best case, and available data)
• Provide project management and logistical support for all agency interactions
• Proactively identify potential issues, constraints, bottlenecks, risks, gating items and mitigation management and escalates issues, as needed; propose solutions to support decision-making for the NDA/MAA
• Clearly and proactively communicate with leadership and program teams in a concise and timely manner: this can comprise written reports at desired cadence, visual aids/tracking systems to display progress and at-risk items for the NDA/MAA
• Assist team in scheduling regulatory cross functional meetings, capturing minutes, disseminating minutes and ensuring follow ups
• Ensure awareness, visibility and planning for regulatory submissions and effectiveness and efficiency in working towards ensuring timely submissions
• Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, risks for ACH and HCH
• Ensure review timelines are adequately managed across all key deliverables
• Update and maintain online documentation management systems
• Work within Veeva RIM to manage submission content plans, execute reports and dashboards, setup document development, and track health authority interactions  
• Provide a positive influence on the functioning of teammates and the team as a whole 

Where You’ll Work

• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA or Palo Alto, CA offices for company events and critical business meetings.

Who You Are

• Master’s degree in a scientific subject. PMP certification desirable
• 3+ years of experience in regulatory project management capacity with filing experience preferred
• 3+ years of hands-on project management experience at a fast-paced company is preferred
• Experience with Veeva RIM and eCTD formats and submission procedures for global filings preferred  
• Experience with timeline management tools (Smartsheet, MS Project, P6)
• Proactive and engaged
• Helpful, positive, team player mindset
• Critical thinking/problem solving and interpersonal communication skills
• Highly organized, meticulous attention to detail
• Ability to multi-task and handle pressures of a fast-paced environment  
• Demonstrated development of leadership skills, collaborating and influencing cross-functionally

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities